Patella Fracture : A Randomized Controlled Trial

Aging Clinical Trial

Official title:

A Prospective Randomized Trial of Non-operative Versus Operative Management of Patella Fractures in the Elderly

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03445819
• Other study ID #: Patella RCT 2018
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2021
• Source: Unity Health Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multi-centre, randomized controlled trial comparing operative and non operative treatment for displaced patella fractures in elderly, low-demand patients.

Description:

Patients with a displaced patellar fracture who meet the inclusion criteria and provide consent will be randomized to one of the two treatment arms. One group (Group A) will receive standardized non-operative treatment with immediate weight-bearing as tolerated in a knee immobilizer and early ROM exercises begun at 2 weeks post injury. The other group (Group B) will receive ORIF of their displaced patellar fracture with a standardized post-operative protocol. Post-operative rehabilitation will be standardized across both groups. Patients will be weight bearing as tolerated immediately in a removable knee immobilizer, with progressive range-of-motion exercises begun at two weeks following surgery or randomization. The knee immobilizer will be used full-time (with the exception of removal for physiotherapy and bathing) for 6 weeks after surgery or randomization. At six weeks post-treatment, patients will be allowed to perform active extension and will initiate progressive strengthening exercises of the extensor mechanism.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 84
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Male or female patients 65 years of age or older and ambulatory prior to injury (with or without walking aids).
• Closed fracture of the patella displaced by 5 mm or greater (Displacement will be determined by measuring the widest displacement on any x-ray view with the knee in full extension).
• The patient scores between 3 and 6 on the Clinical Frailty Scale. This score corresponds to a low-demand patient who is ambulatory and functionally independent
• Within 14 days of injury, the patient is able to perform a straight leg raise with less than 30 degrees of extensor lag.
• Able to read and understand the study consent form document.
• Willing and able to sign consent, follow the study protocol and attend follow-up visits.

Exclusion Criteria:

• Associated extremity injuries or polytrauma injuries that would otherwise require surgery or interfere substantially with rehabilitation or outcome in the opinion of the investigator.
• Neurovascular injuries at the level of the knee requiring surgery.
• Pathologic fractures.
• Periprosthetic fractures, or other knee surgery which would contra-indicate inclusion in the study (e.g. previous patella ORIF or previous surgery involving patella such as patella tendon or quads repair).
• Medical contra-indication to surgery.
• Likely problems, in the judgment of the investigators, with maintaining follow-up (e.g. patients with no fixed address, intellectually challenged patients without adequate support, etc.).

Related Conditions & MeSH terms

• Aging
• Fractures, Bone
• Patella Fracture

Intervention

Procedure:
• Group A: Surgical Treatment
Open reduction and internal fixation (ORIF) of the patellar fracture will be performed using screws, wires, pins, or plate fixation at the discretion of the treating surgeon

Other:
• Group B: Conservative Treatment
Patients randomized to non-operative treatment will receive identical treatment to the operative group, minus the surgery.

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Unity Health Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	TUG Test	Timed Up and Go test	up to 24 months
Primary	Knee injury and Osteoarthritis Outcome Score (KOOS)	A self-administered questionnaire that assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.	1 year after injury
Secondary	Visual Analogue Pain Scale (VAS)	VAS consists of a straight line with the endpoints defining extreme limits of pain, ranging from 'no pain at all' (zero) to 'pain as bad as it could be' (10)	1 year after injury
Secondary	Range of Motion	Measurement of flexion and extension	up to 24 months